EMA IDMP Directive
The European Medicines Agency (EMA) has implemented the Identification of Medicinal Products (IDMP) standards to improve the safety and efficacy of medicines in the European Union (EU). The EMA has directed pharmaceutical companies to comply with the IDMP standards for all medicinal products. In this essay, we will discuss the EMA IDMP Directive and how it affects the pharmaceutical industry.
What is IDMP?
The IDMP standards are a set of global standards that provide a unique identification system for medicinal products. This system includes information on the product’s composition, packaging, and manufacturer. The goal of the IDMP standards is to improve patient safety and support regulatory decision-making by providing accurate and complete information on medicinal products.
Why is IDMP important?
The IDMP standards are important for the safety and efficacy of medicinal products in the EU. By providing a unique identification system, the IDMP standards allow for accurate and complete information on medicinal products to be available to regulatory authorities, healthcare professionals, and patients. This helps to prevent medication errors, improve patient safety, and support regulatory decision-making.
Reporting Requirements in IDMP Directive
Pharmaceutical companies must report information on their medicinal products to comply with the IDMP standards. This includes information on the product’s composition, packaging, and manufacturer. Companies must also report any changes to this information within a specific timeframe.
Submission Process in IDMP Directive
Pharmaceutical companies must submit information on their medicinal products to the EMA through the ISO IDMP standard. The information must be provided in a specific format that complies with the IDMP standards. Companies must ensure that the information they provide is accurate and up-to-date.
Compliance in IDMP Directive
Pharmaceutical companies must comply with the IDMP Directive to ensure that their medicinal products can be marketed in the EU. Failure to comply with these regulations can result in regulatory action, including the suspension or revocation of a product’s authorization. Companies must ensure that they keep their product information up-to-date in the IDMP system.
Data Access in IDMP Directive
The IDMP system is accessible to regulatory authorities, healthcare professionals, and patients. The information contained in the IDMP system is confidential and can only be accessed by authorized parties. The IDMP system allows for accurate and complete information on medicinal products to be available to support patient safety and regulatory decision-making.
Future Developments
The EMA is constantly evolving the IDMP standards to improve the safety and efficacy of medicinal products in the EU. The EMA is working on implementing a new database, the EU Product Information Management System (EU-PIMS), which will replace the current IDMP system. The EU-PIMS will provide a more comprehensive and streamlined way for pharmaceutical companies to report information on their medicinal products.
The EMA IDMP Directive plays a crucial role in improving the safety and efficacy of medicinal products in the EU. The IDMP standards allow for accurate and complete information on medicinal products to be available to regulatory authorities, healthcare professionals, and patients. Pharmaceutical companies must comply with the IDMP Directive to ensure that their medicinal products can be marketed in the EU.
XEVMPD Management Software
Templarpharma’s XEVMPD management systems are easy-to-use, hosted, On-Demand web-based solution for information management for XEVMPD content authoring with state-of-the-art navigation and User interface components. designed the application to address the laborious data entry requirements of complying with XEVMPD regulations. The application facilitates modular data entry screens for each submission component, allowing for granular authoring and data entry validation. This enables users to enter data in components and validate them in a modular fashion without the need to wait for all submission components to be complete.
XEVMPD Management System Features
Templarpharma’s XEVMPD management system is a web-based solution that offers easy-to-use features for XEVMPD content authoring. The application includes state-of-the-art navigation and user interface components that make data entry easy and error-free. The system supports modular data entry screens that enable granular authoring and component level data entry validation.
XEVMPD System Lifecycle Management
- The XEVMPD system provided by Templarpharma supports lifecycle management of XEVMPD data submitted to EMA.
- The system enables automated updating of EMA assigned EV code to local code mapping.
- It allows for XEVMPD management for future updates and communication to EMA.
- The application tracks changes and generates updated delta XEVMPD compliant XML files.
- Templarpharma’s XEVMPD system offers comprehensive security and workflow features.
- The system supports authoring, review, approve, publish, and archival processes.
Product Features
- State-of-the-art Navigation & User Interface Components
- Assured Data Security from creation to storage
- Modular Component based Granular Authoring
- Comprehensive Security and Workflow Features
- Reference Look-ups
- Life-cycle Management
Templarpharma IDMP on-Demand Solution
- The solution eliminates the need for companies to invest in overwhelming software license fees, infrastructure and training.
- No customer hardware or software is required, as the solution is hosted on the cloud.
- The On-Demand IDMP solution provides a low-cost alternative to the conventional in-house development or upfront purchase of IDMP software license.
- Companies can access the solution from anywhere and at any time with an internet connection.
- The solution provides secure and reliable data storage and management.
- Templarpharma’s experts provide guidance and support to ensure smooth implementation and compliance with regulatory requirements.
Key Benefits in IDMP Directive
- Ready-to-use, Web-Based, On-Demand Solution
- Minimal setup and Out-of-the-box solution
- Saves Time
- No Lead Time lost in ‘Building a System’
- No Preliminary Implementation required
- Minimal start-up Cost
- Simple and Cost Effective Licensing Model
- Online Training and Support
The XEVMPD/IDMP 360
- The solution can also function as an information collation and repository system.
- The platform provides the framework required for an end-to-end enterprise scale XEVMPD/IDMP application when combined with our XEVMPD/IDMP Convertor.
- Templarpharma XEVMPD/IDMP Conversion Services: Based on the overall XEVMPD/IDMP conversion and maintenance strategy, Templarpharma can undertake XEVMPD/IDMP XML conversion from diverse sources.
- The solution offers a user-friendly interface and customizable workflows to meet specific business requirements.